For the latest QIDP listing, please click HERE
Since FDA issued the QIDP designation in 2012, many companies have requested this important ‘label’. Which should not come as a surprise: QIDP status confers significant benefits – and there is no downside.
My quick Google search identified 26 compounds. While most are from known antibiotic drug classes, they all have expanded spectra or PK/PD benefits over existing drugs. Of interest, some compounds have changed hands or entered into co-development deals with large(r) Pharma companies.
UPDATE 3: Dalbavancin (Dalvance), oritavancin (Orbactiv), and tedizolid (Sivextro) were recently approved and are no longer listed here.
NOTE: Some drugs have transitioned from Phase 2 into Phase 3 since the table was first published 2 months ago.
NOTE: Please search this site for other blogs related to QIDP;
the latest update is from 3/28/2015, with a searchable table of all drugs
The table below lists only systemic drugs in Phases 2 or 3 which garnered the QIDP designation. MK-7655 (Relebactam) is the most recent addition to our list. Interestingly, there are no new antibiotic classes on the list; the group of FabI inhibitors (there are at least 3 in development) so far did not seek or has not received QIDP status.
|Drug Name||Company||Phase||Antibiotic Class|
|Ceftazidime + avibactam||Actavis||Phase 3||B-lactam / BLI|
|Ceftolozane + tazobactam||Cubist||Phase 3||B-lactam / BLI|
|Fusidic Acid||Cempra||Phase 2||fusidic acid|
|Imipenem/cilastatin + MK-7655||Merck||Phase 2||B-lactam / BLI|
|Meropenem + RPX7009||The Medicines Comp (Rempex)||Phase 3||B-lactam / BLI|
|Nemonoxacin||TaiGen Biotechnology||Phase 3||quinolone|
|Solithromycin||Cempra||Phase 3||macrolide / ketolide|